Supporting Pharmacometrics Education at the University of Maryland

Nelson Mandela is quoted with saying, “Education is the most powerful weapon which you can use to change the world.” At Certara, we are helping change the world by aiding the development of novel medications through our technology-enabled solutions. Indeed, supporting the education of the next generation of pharmacometricians is essential to our mission. In this blog post, I’ll discuss our recent gift in kind of Phoenix software licenses to the University of Maryland School of Pharmacy’s Center for Translational Medicine (CTM).

Phoenix: a PK/PD modeling and simulation platform for industry and academia

Certara’s Phoenix software platform is used to manage, analyze and report pharmacokinetic, pharmacodynamic and toxicokinetic data. It is employed by pharmaceutical, veterinary and academic researchers, along with the FDA and other global regulatory agencies, to understand the safety and efficacy profile of drugs in development. I’m particularly proud of the fact that this intuitive and easy-to-use software is used by more than 3500 students, researchers and instructors at leading pharmacy and medical schools around the globe. In fact, a recently published paper from the International Consortium for Innovation and Quality in Pharmaceutical Development in the American Association of Pharmaceutical Scientists Journal stated that Phoenix WinNonlin was used by 100 percent of the pharmaceutical companies surveyed to support pre-clinical research.

Supporting education through the Phoenix Centers of Excellence

The CTM was founded in the Department of Pharmacy Practice and Science (PPS) at the School of Pharmacy in 2011 by Joga Gobburu, PhD, who came the University from the FDA. There are currently 45-50 postgraduate students enrolled in this unique program: a four-year, online master’s degree in pharmacometrics. The CTM analyzes and summarizes data from experiments and clinical trials using quantitative disease, drug, and trial models with a goal of reducing the time it takes to bring a drug to market. Its quantitative models, along with cutting-edge development techniques such as adaptive and enrichment trials, are integrated into tools that drug developers, regulatory agencies, and other research organizations can use to guide decisions pertaining to “go/no-go,” dosage, patient population, design, endpoint, analyses, and therapeutics choices.

We developed the Phoenix Centers of Excellence Program to enhance research and training in pharmaceutical sciences at several elite academic centers. About two years ago, Certara selected the University of Maryland’s CTM as one of its U.S. Phoenix Centers of Excellence. We are providing the CTM with Phoenix software licenses for teaching and research purposes, and also delivering training and workshop assistance. By supporting the CTM, their students will gain valuable practical experience by training on Certara’s state-of-the art modeling and simulation software and then co-developing novel Phoenix features with our experts.

Our goal is to combine CTM’s research, clinical, and educational expertise with Certara’s IT infrastructure to generate new, innovative approaches to improve public health. On January 29th, I had the honor of speaking at a luncheon at the University of Maryland’s School of Pharmacy during which the donation was formally given to William E. Kirwan, chancellor of The University System of Maryland. I also had the pleasure of meeting Drs. Natalie D. Eddington PhD, FAAPS, FCP, professor and chair of the School of Pharmacy and executive director of University Regional Partnerships and Magaly Rodriguez de Bittner, PharmD, professor and chair of PPS.

Pharmacometrics: a burgeoning field for today’s students

Pharmacometrics is an important and growing field for researchers, sponsors and regulators. In this time of economic uncertainty, it offers excellent career opportunities for students. Pharmacometric modeling and simulation is a particularly powerful tool for several reasons:

It can be used to determine appropriate drug doses, labeling and clinical trial design.

It can be used to explore otherwise untestable populations, such as pediatric patients and those with rare diseases or complex co-morbidities.

It can assist in clinical trial design and drug dose selection for late-phase trials based on data collected in earlier phases.

Essentially, pharmacometric modeling and simulation helps to optimize and increase the predictability of the most crucial R&D and regulatory decisions, helping to bring new, safer therapies to patients more efficiently.

Leverage our training opportunities

We strive to help our academic and commercial users get as much value out of their Phoenix software as possible.That’s why we offer training for everyone— from beginner to advanced users. Our courses are taught by expert instructors like Dr. Daniel Weiner, the creator of WinNonlin. He is an undisputed expert who, literally, wrote the book on PK/PD modeling, “Pharmacokinetic & Pharmacodynamic Data Analysis.” Indeed, 9 out of 10 customers, who have taken Phoenix training courses, have rated our instructors’ ability to clearly present concepts as either “good” or “excellent.” And students can take advantage of up to 50% discounts on training courses that are discounted to the public.

All information presented derive from public source materials.

Learn how a CTM student leveraged Phoenix NLME

Dr. Tim Cacek, a graduate of their Master’s degree program in pharmacometrics, used Phoenix during his thesis research. Watch this webinar to learn about his journey through his introduction to Phoenix NLME, and how it has become his primary tool for population modeling.

About the Author

Ms Leinfuss brings more than 25 years of experience leading marketing, business development and sales management groups for technical and scientific-based organizations. She spent the last nine years at UL EduNeering, a global provider of regulatory compliance educational solutions, delivered via cloud-based technology. At UL, Ms. Leinfuss directed the strategic development of the company’s solutions to the life science market, including pharmaceutical, medical device, biologics, clinical, and managed care health plans. In addition, she managed the Company’s strategic alliances, including the Company’s 15 year Cooperative Research and Development Agreement (CRADA) with the US FDA and its exclusive partnerships with AdvaMed and the Personal Care Products Council, among others. Ms Leinfuss possesses a Master's in Business Administration in marketing from the City University of New York and Bachelor's in Chemistry from the State University of New York.